Clinical Data Management

img02ClinSoft understands that the client needs a robust team for enhancing the speed of the trial; managing the enormous data emerging from the trials and streamlining it to make it available for analysis. ClinSoft foundation is built on excellence in clinical data management, from trial case report form (CRF) design through to database lock.
“Excellence and Quality” has been used by many clinical trial sponsors when describing their experience with ClinSoft’s clinical data management team and services.

ClinSoft offers both electronic data capture (EDC) and paper/fax-based solutions that are customizable and cost-effective for clinical trial data management.

The following Data Management Services are provided by ClinSoft :

  • Data capture and management using both EDC and paper/fax-based systems.
  • CRF/eCRF design and annotation.
  • Data management plan writing and maintenance.
  • Database design and maintenance.
  • Data processing and quality control, including third party data integration and cleaning (e.g. central lab data, eDiaries, etc.).
  • Safety data review and reconciliation of adverse events and serious adverse events.
  • Medical terminology coding using MedDRA and medication coding using WHODRUG.
  • Database QA acceptance sampling prior to database lock, and additional database checks by our statistical team.
  • Secure web portal for real-time access to study progress reports, query reports, subject data listings and summary tables, etc.
  • Ongoing support for users of data management systems and tools, including user training and help desk operation.
  • Database lock.
  • Database archival.
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